Product code

BZC: Calculator, pulmonary function data

FDA product code · Class II · Anesthesiology

Key facts

Product code BZC
Device Calculator, pulmonary function data
Device class Class II
Regulation number 868.1880
Review panel Anesthesiology
Medical specialty Anesthesiology
Submission type 510(k)
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No

At a glance

  • 10–99 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • 100–999 UDI devices (GUDID)
  • 10–99 MAUDE adverse event reports
  • 1–9 Recalled products (Z-numbers)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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